PROOF OF CONCEPT III – Combination with Immune Checkpoint Inhibitors (ICI)

INVION | PoC III: COMBINATION WITH IMMUNE CHECKPOINT INHIBITORS

Melbourne (Australia) 30 May 2022: Invion Limited (ASX: IVX) is please to announce the findings from the third Proof-Of-Concept (PoC) study undertaken by its research partner, Hudson Institute of Medical Research (Hudson Institute).

The PoC was specifically designed to evaluate whether INV043 can be used in combination with immune checkpoint inhibition targeting PD-1 to improve outcomes in mice with triple negative breast cancer (TINBC).

Unlike previous PoC studies, administration was restricted to a small portion of the tumour to specifically probe the combination approach and immune-mediated changes following therapy in an animal model.

Additive Benefits Combining INV043 with Checkpoint Inhibitoirs

  • Previously announced Proof of Concept II, performed on immunocompetent in vivo models, demonstrated complete tumour regression in a mouse model of triple negative breast cancer (TNBC) following optimal treatment using INV043.
  • Subsequent Proof of Concept work has been focused on characterising the immune response, which will ultimately help in optimising treatment protocols for clinical applications.
  • One study conducted evaluated whether INV043-PDT could be used as an immune-stimulatory therapy to enhance immune checkpoint efficacy. It was designed to monitor tumour regression from immune checkpoint inhibitor (“ICI”) therapy, and the impact of combining this with INV043 (administered on a restricted basis).

Findings

  • There was a clear additive effect when INV043-PDT and immune checkpoint inhibition targeting the PD-1 / PD-L1 axis were combined. This resulted in significantly enhanced tumour regression in vivo vs the ICI treatment alone
    tumour regression in a mouse model of triple negative breast cancer (TNBC) following optimal treatment using INV043.
  • Mice treated with combination therapy had ~65% reduction in tumour size at endpoint; and tumours were also significantly smaller than those in mice that received standalone therapy.

Conclusion and Next Steps

  • These results provide a compelling rationale for the use of INV043 in combination approaches, to prime the tumour microenvironment and enhance the efficacy of checkpoint inhibition in immunologically “cold” tumours such as TNBC.
  • Moreover, the already established applicability of INV043 against multiple cancer types suggests broad clinical relevance for the treatment of established, drug-resistant disease.
  • Ongoing data analyses will identify the key features of induced immunity following INV043 treatment, and how these are influenced by the combination with anti PD-1. Specific biomarkers to assess treatment response will also be identified, necessary to guide clinical decision making around treatment protocols as INV043 moves towards clinical trials.

Making crucial progress in combination therapy with ICI is of paramount importance given that only a small proportion of patients respond to ICI therapy, and many will relapse.